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NCT05697562
Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Conditions: Hemorrhoids
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 80
Sponsor: Universitair Ziekenhuis Brussel
Summary
SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma.
Feasibility, efficacy and safety were studied in several trials.
A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD.Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery.
Furthermore, DG-HAL and RBL are equally effective procedures.
The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).
Eligibility Criteria
Inclusion Criteria:All patients referred for Hemorrhoidal disease with bleeding are eligible.
Significant bleeding is defined as a HBS of ≥ 5.Age > 18 years old;Sexes eligible for study: allHemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptomHistory of prior instrumental treatment of HD does not prohibit inclusionAble to understand and read Dutch, French or EnglishExclusion Criteria:Permanent hemorrhoidal prolapse/grade IV hemorrhoidal diseaseRectal prolapseHistory of proctological surgery for HDAcute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)Anal stenosis, congenital of acquiredChronic anal fissureActive rectal inflammation, including peri-anal abscess (e.g.
Inflammatory Bowel Disease, infectious,…)History of colorectal or anal cancerHistory of rectal or sigmoidal resectionPortal hypertension and liver cirrhosis Child Pugh CRadiation rectitisNeurological disease involving anal sphincter musculatureSevere psychiatric disorderPregnancyAllergy to iodinated contrast agentsColorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)
Source: ClinicalTrials.gov (NCT05697562). StuddyBuddy aggregates publicly available trial information.